The present invention is directed to a simple and economical device for securely holding a solid state diode in place on a patient for the duration of a single radiation treatment and for a method of placement of the device for monitoring measurement readings during the radiation treatment. More particularly, in embodiments, the present invention relates to a novel disposable device that secures placement of the diode directly on the surface of the point of interest target on the patient, allowing for monitoring by continuously visualizing the diode. This device comprises foam tape that surrounds the diode and provides a secure hold for the cable attached to the diode. The adhesive is designed for adherence to the surface of the skin of the patient and to any other solid surface where radiation monitoring is needed. The device further comprises a transparent adhesive center that securely allows for visualization of the diode to ensure accurate placement. The transparent adhesive center is made of material that allows for reliable diode measurement readings, which are essential for accurate dosage in radiation treatment settings.
Over 1.2 million people will receive radiation treatment in the U.S. this year alone. Each of those patients will have a patient treatment dose report that verifies the calculated dose rate to each dose point of interest. Avoiding excessive radiation exposure or misadministration of radiation dose is important in radiation treatment. Additionally, repeatability is important where multiple treatments are common. Each diode must be positioned and repositioned accurately for each radiation therapy treatment to ensure that the proper radiation dose is delivered to the diseased tissue, avoiding the healthy tissue as much as possible. The ideal device preferably will be flexible, allowing it to adhere to curved body surfaces. It also preferably will be capable of use with adults, children, and babies, and for use on various locations of the body.
The use of solid state diodes for monitoring radiation doses to patients during treatment has become the standard in quality assurance. The diode needs to be held in direct contact with the body for a period of time. It often is moved to a different point of interest during the same treatment regime. While the diode is highly technical in the ability to read radiation doses, the ability to securely place it on a patient at a point of interest to monitor the amount of the radiation received has been a problem with which radiation therapists have struggled since the inception of the solid state diode.
The diode itself does not have any properties that allow it to adhere to the patient. Therefore, external mechanisms are used to hold the diode in place. The most common method for holding the diode onto a patient is with conventional tape. This tape is often either made from paper or is masking tape. The use of tape is less than ideal. Many times the tape blocks the ability to see the diode during the treatment so monitoring is less efficient. Additionally, the adhesive on the tape does not provide for adequate adhesion to the curved surface of the body for the duration of the treatment. The tape also leaves an undesirable residue of adhesive both on the diode and on the skin.
Attempts have been made to address these problems for adhering sensors and probes to the patient's body. For example, U.S. Pat. No. 5,090,410 to Saper, incorporated by reference in its entirety herein, describes a fastener for attaching a sensor to the body. The sensor is attached through the use of a sleeve, which in turn is attached to an adhesive bandage. The bandage, while making the sensor more stable to the patient's body, does not provide an adequate structure to hold the diode sufficiently dose to the patient's skin. Furthermore, the shape and size of the design of this fastener would not take into account the size of the diode and are therefore not applicable for use with a solid state diode. While U.S. Pat. No. 6,748,254 to O'Neil contains a plurality of stacked adhesive layers with the topmost adhesive layer attached to the patient's skin, the optical sensor of interest is built into the applicator. Such a device would not accommodate the solid state diode because visualization of the target and diode placement would be impossible. Additionally, this device would not hold the diode on the surface of the patient.
U.S. Pat. No. 8,190,229 to Lowery holds a sensor in an interior cavity that can be adhered to the patient's skin. The overall design contains flaws for radiation treatment with the solid state diode because the flanges of the roof portion of the device would prevent visualization of the target and of the diode. This would not allow accurate placement. Additionally, the pressure application portion would prevent the diode from being placed directly on the target. A device such as the one in U.S. Pat. No. 6,295,463 to Stenzler would impede the ability to get an accurate reading because the mount is between the sensor and the target.
Methods and devices intended for radiation treatment such as U.S. Pat. No. 8,480,684 to Bendre are simply positioning devices and not capable of allowing for visualization during treatment. These methods are unreliable in the treatment and do not allow visualization of the target. All above-mentioned patents are incorporated by reference in their entireties.
Problems with the current external mechanisms include: lack of visualization of the target; improper placement of diode; lack of consistent adhesion during monitoring; and lack of consistent adhesion in adjusting the placement of the diode. There is no current technology that meets the specific needs of the diode application and addresses these problems.
From the above discussion, it is apparent that what is desired is a dedicated device to hold the solid state diode onto a patient during dose monitoring and to ensure proper radiation treatment with monitoring in real time during the radiation procedure. The present invention is an effective method for visualizing the target, and it is made of materials that are reliable in adhesion to the skin. It delivers accurate and reliable placement of the monitoring device on the patient and is uniquely designed for use with a solid state diode, thus addressing the problems of the current technology. In addition, there are lower repeat rates of diode readings with the present invention, and the setup time for a diode reading is reduced. Additionally, the present invention is sufficiently sized to use with adults, children, and babies.
Any references mentioned are not admitted to be prior art with respect to the present invention.